17Pushing Boundaries: The Landscape of AI-Driven Drug Discovery and Development with Insights Into Regulatory Aspects

Dipak D. Gadade1*, Deepak A. Kulkarni2, Ravi Raj1, Swapnil G. Patil3 and Anuj Modi1

1Department of Pharmacy, DSEU Dwarka Campus, Delhi Skill and Entrepreneurship University, Government of NCT of Delhi, New Delhi, India

2Department of Pharmaceutics, Srinath College of Pharmacy, Bajajnagar, Aurangabad (M.S.), India

3Drugs Control Department, Government of NCT of Delhi, Karkardooma, Delhi, India

Abstract

Artificial intelligence (AI) is revolutionizing the field of pharmaceutical and healthcare sector. The current understanding of drug development (DVPT) and discovery can be expanded with the aid of AI to benefit the health of the society. Current opportunities, where AI can be helpful include support in preclinical and clinical studies, target identification, hit identification, lead optimization, and clinical decision-making. The challenges that AI should overcome includes ethical aspects, intellectual issues, and regulatory aspects in drug DVPT and its clinical establishment. AI has various applications in drug discovery (DDS) and DVPT. The overall goal is to accentuate the importance of drug discovery and DVPT as well as the potential for AI to streamline the procedures and enhance better health outcomes. Furthermore, the recent updates of DVPTs in AI-related issues in regulatory affairs are highlighted in this chapter along with key moves that the pharmaceutical ...

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